NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

•

more than 4,000 mg of acetaminophen in 24 hours

•

with other drugs containing acetaminophen

•

3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

•

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

•

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

•

to make a child sleepy

•

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

•

liver disease

•

glaucoma

•

cough that occurs with too much phlegm (mucus)

•

a breathing problem such as emphysema or chronic bronchitis

•

trouble urinating due to an enlarged prostate gland

•

persistent or chronic cough as occurs with smoking, asthma, or emphysema

•

a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

•

taking sedatives or tranquilizers

•

taking the blood thinning drug warfarin

When using this product

•

excitability may occur, especially in children

•

marked drowsiness may occur

•

avoid alcoholic drinks

•

be careful when driving a motor vehicle or operating machinery

•

alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

•

pain or cough gets worse or lasts more than 7 days

•

fever gets worse or lasts more than 3 days

•

redness or swelling is present

•

new symptoms occur

•

cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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